Gene Arey
FDA investigator
Appears on 6 documents from 2015 to 2022, most often at sites in North Carolina. Most often cites production record review (21 CFR 211.192).
- 6
- Documents on file
- 4.8
- Observations per 483
- 2015
- First seen
- 2022
- Most recent
What they cite most
From 23 observations- 21 CFR 211.192Production record review8
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.160General requirements1
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.67Equipment cleaning and maintenance1
Activity by year
2015: 1, 2016: 2, 2018: 1, 2019: 1, 2022: 1
Where
North Carolina 2 · Spain 1 · Switzerland 1 · United Kingdom 1
Often inspects with
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Inspection history
6 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2022-09-23 | 483 Form 483 · FEI 3011292311Sep 23, 2022 | — | 1 | |
| 2019-06-25 | 483 Instituto Grifols, S.A.Jun 25, 2019 · Parets Del Valles, Spain | Parets Del Valles, Spain | 2 | |
| 2018-04-24 | 483 Valneva Scotland Ltd.Apr 24, 2018 · Livingston, United Kingdom | Livingston, United Kingdom | 7 | |
| 2016-10-21 | 483 Grifols Therapeutics LLCOct 21, 2016 · Clayton, North Carolina | Clayton, North Carolina | 7 | |
| 2016-05-17 | 483 Seqirus IncMay 17, 2016 · Holly Springs, North Carolina | Holly Springs, North Carolina | 4 | |
| 2015-09-11 | 483 Bavarian Nordic Berna GmbHSep 11, 2015 · Thörishaus, Switzerland | Thörishaus, Switzerland | 8 |
About this profile
What does Gene Arey inspect?
Gene Arey appears on 6 documents on file covering 6 sites, most often in North Carolina.
What do they cite most often?
21 CFR 211.192 (production record review), followed by 21 CFR 211.100 and 21 CFR 211.22.
Can I read the observations?
Each document page previews the opening words of every observation. The full documents are available to buy, one at a time or together.
How current is this profile?
The most recent document on file for Gene Arey is dated Sep 23, 2022.